Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers

Brief summary public domain (ClinicalTrials.gov)

The study intervention consists of the early integration of palliative care services into standard oncology care in an outpatient setting for patients with advanced lung and non-colorectal gastrointestinal malignancies who are not being treated with curative intent. The palliative care services provided to patients randomized to the intervention will be provided by board-certified physicians and/or advanced practice nurses and will focus on the following areas: (1) developing and maintaining the therapeutic relationship with the patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing support and reinforcement of coping with advanced cancer in patients and family caregivers; (4) assessing and enhancing prognostic awareness and illness understanding in patients and family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care planning.

Detailed description public domain (ClinicalTrials.gov)

There will be about 400 patients enrolled in this intervention study and there will be about 300 family caregivers enrolled as well. This study will consist of two study groups as previously described. The effects of the early involvement of the palliative care team will be compared to the usual approach of receiving care mostly from the cancer treatment team. The stratification factors include tumor type (lung vs. esophageal/gastric vs. hepatic/biliary/pancreatic) and family care giver participation (yes vs. no). Patients will be on this study for as long as they receive care. Institutions must have an outpatient palliative care clinic that meets the study site requirements as defined in the protocol. The outpatient clinic leadership must include a physician and/or advanced practice nurses board certified in palliative care. The primary and secondary endpoints are described below. Primary Endpoint: To determine the efficacy of early integrated palliative care on patient reported quality of life at 12 weeks using the FACT in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer Secondary Endpoints: * To determine the efficacy of early integrated palliative care on other patient reported outcomes in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints defined in the protocol * To determine the efficacy of early integrated palliative care on family caregiver reported outcomes in those newly diagnosed incurable lung or non-colorectal gastrointestinal cancer, by assessing the endpoints defined in the protocol * To assess the impact of early integrated palliative care on the quality of end-of-life care and resource utilization in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer by assessing the endpoints defined in the protocol * To determine concordance between patient and family caregiver report of prognosis/ curability

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G) [Up to 12 weeks]. Mean, units on a scale (Standard Deviation). Arm 1 (Early Palliative Care) (n=92): 3.35 (14.7); Arm 2 (Usual Care) (n=101): 0.12 (12.7). Analysis, Arm 1 (Early Palliative Care) vs Arm 2 (Usual Care): Mean Difference (Final Values) 3.23 (95% CI -0.67 to 7.13); p=0.104; ANCOVA; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G) [Up to 24 weeks]. Mean, units on a scale (Standard Deviation). Arm 1 (Early Palliative Care) (n=68): 3.80 (15.3); Arm 2 (Usual Care) (n=80): 0.69 (13.3). Analysis, Arm 1 (Early Palliative Care) vs Arm 2 (Usual Care): Mean Difference (Final Values) 3.12 (95% CI -1.54 to 7.77); p=0.188; ANCOVA; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression [Up to 12 weeks]. Mean, units on a scale (Standard Deviation). Arm 1 (Early Palliative Care) (n=100): 0.54 (4.0); Arm 2 (Usual Care) (n=112): 0.46 (3.6). Analysis, Arm 1 (Early Palliative Care) vs Arm 2 (Usual Care): Mean Difference (Final Values) 0.08 (95% CI -0.94 to 2.09); p=0.884; ANCOVA; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety [Up to 12 weeks]. Mean, units on a scale (Standard Deviation). Arm 1 (Early Palliative Care) (n=100): -1.13 (2.7); Arm 2 (Usual Care) (n=111): -0.32 (2.8). Analysis, Arm 1 (Early Palliative Care) vs Arm 2 (Usual Care): Mean Difference (Final Values) -0.81 (95% CI -1.54 to -0.07); p=0.033; ANCOVA; superiority.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Prognostic Understanding at Week-12 as Measured by "Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?" Question on the Prognosis and Treatment Perceptions Questionnaire [Up to 12 weeks]. Count Of Participants, Participants. Yes: Arm 1 (Early Palliative Care) (n=99): 30; Arm 2 (Usual Care) (n=110): 16. No: Arm 1 (Early Palliative Care) (n=99): 69; Arm 2 (Usual Care) (n=110): 94. Analysis, Arm 1 (Early Palliative Care) vs Arm 2 (Usual Care): p=0.006; Chi-squared; superiority.